Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome
NCT04705220, Not applicable, Completed, Indena S.p.A
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome | ClinicalTrials.gov |
| NCT number | NCT04705220 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 85 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Indena S.p.A | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment | ClinicalTrials.gov |
| Interventions | MERIVA® Tablets, Placebo Tablets | ClinicalTrials.gov |
| First posted | 2021-01-12 | ClinicalTrials.gov |
| Last updated | 2026-02-02 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from Baseline of Mini-Mental State Examination (MMSE) Test | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Percentage of subjects showing an improvement in performance in Mini-Mental State Examination (MMSE) test in comparison to baseline, defined as an increase of more than 2 points in the test. A difference between the group treated with MERIVA® versus placebo of at least 20% in the proportion of subjects with clinical improvement as defined above is considered clinically relevant. The differences between genders are considered. | ClinicalTrials.gov |
| Primary | Change from Baseline of Montreal Cognitive Assessment (MOCA) Test | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Percentage of subjects showing an improvement in performance in Montreal Cognitive Assessment (MOCA) test in comparison to baseline, defined as an increase of more than 2 points in the test. A difference between the group treated with MERIVA® versus placebo of at least 20% in the proportion of subjects with clinical improvement as defined above is considered clinically relevant. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Rey's Auditory Verbal Learning Test (RAVLT) Test | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the neuropsychological measurement performed regarding memory tests (Rey's Auditory Verbal Learning Test - RAVLT). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Trail Making Test (TMT) Test | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the neuropsychological measurement performed regarding executive functions and attention (Trail Making Test - TMT). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Multiple Features Target Cancellation (MFTC) Test | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the neuropsychological measurement performed regarding executive functions and attention (Multiple Features Target Cancellation - MFTC). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Phonological and Semantic Verbal Fluidity (FVS) Test | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the neuropsychological measurement performed regarding language (Phonological and Semantic Verbal Fluidity - FVS). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Geriatric Depression Scale (GDS) Test | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the neuropsychological measurement performed regarding a neuropsychiatric scale (Geriatric Depression Scale - GDS). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Neuro-Psychiatric Inventory (NPI) Test | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the neuropsychological measurement performed regarding a neuropsychiatric scale (Neuro-Psychiatric Inventory - NPI). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Basic Activities of Daily Living (BADL) Test | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the neuropsychological measurement performed regarding the ability to live everyday (Basic Activities of Daily Living - BADL). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Instrumental Activities of Daily Living (IADL) Test | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the neuropsychological measurement performed regarding the ability to live everyday (Instrumental Activities of Daily Living - IADL). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Stroop Test - Short Version | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the neuropsychological measurement performed regarding executive functions and attention (Stroop test short version). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Bioelectrical Impedance (BIA) Assessment | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of body composition by bioelectrical impedance (BIA). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Metabolism Parameters measured in Blood | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of metabolism changes (blood panel including: total cholesterol, Low-Density Lipoproteins, High-Density Lipoproteins, insulin, triglycerides, glucose, creatinine, uric acid, electrolytes, hepatic transaminases, gamma-glutamyltransferase, total proteins). In particular, any differences in terms of fasting blood glucose reduction and Homeostatic Model Assessment (HOMA) Index between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Lipid and Immune Profile measured in Blood | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the lipid and immune profile of subjects treated with MERIVA® versus placebo. In particular, an omic-type approach will reveal alterations in lipid and energy metabolism, including lipoproteins, low molecular weight metabolites and individual lipid molecules, together with their degree of (poly) (non) saturation (blood panel including: leptin, adiponectin, Brain-derived Neurotrophic Factor, proinflammatory mediators such as Tumor Necrosis Factor alpha, interleukin-1 beta and interleukin-6, prostaglandins and reactive species of oxygen / nitrogen, inflammasome). The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Change from Baseline of Brain-Derived Neurotrophic Factor (BDNF) and p66Shc Gene Expression measured in Blood | Change from Baseline (T0) to 6 months of treatment (T6). | Evaluation in comparison to baseline of the lipid and immune profile of subjects treated with MERIVA® versus placebo. In particular, a sample of Peripheral Blood Mononuclear Cells (PBMC) will be separated for the measurement of the expression, by means of real-time Polymerase Chain Reaction (RT-PCR), of the neurotrophin Brain-Derived Neurotrophic Factor (BDNF) and of the p66Shc gene, which are involved in the response to lifestyle changes, including diets and exercise. The differences between genders are considered. | ClinicalTrials.gov |
| Secondary | Rate and Characterization of Adverse Events occurred to Subjects | Pre-Screening (T-1) / Baseline (T0) / After 3 months of treatment (T3) / After 6 months of treatment (T6) / After 12 months of treatment (T12). | Evaluation of the number, rate and characteristics of the adverse events occurring to subjects treated with MERIVA® versus placebo. The differences between genders are considered. | ClinicalTrials.gov |
| Other | Intestinal Microbiotic Profile Assessment in Stool Sample | Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12). | Evaluation in comparison to baseline of the intestinal microbiotic profile of subjects. Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 12
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 16556968 | BACKGROUND | PubMed |
| 20739649 | BACKGROUND | PubMed |
| 21115952 | BACKGROUND | PubMed |
| 21514249 | BACKGROUND | PubMed |
| 21514250 | BACKGROUND | PubMed |
| 23524280 | BACKGROUND | PubMed |
| 24605806 | BACKGROUND | PubMed |
| 25277322 | BACKGROUND | PubMed |
| 28537012 | BACKGROUND | PubMed |
| 28952131 | BACKGROUND | PubMed |
| 29445414 | BACKGROUND | PubMed |
| 30156145 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)